• United States Of America, Usa
  • Save Job
  • 5 - 8 Years
  • Posted : above 1 month

Job Description:

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing We continuously forge partnerships that help pursue world-class medicines in new ways, combining our peoples exceptional skills with those of people from all over the globe

Description 12 hour night shift role with rotating days on/off

This position is responsible for all QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions

Essential Job Functions

At this level the incumbent is not necessarily performing all the Essential Job Functions of the role immediately The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs Over time the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role

Maintains a high level of understanding of relevant production processes and quality systems
Performs the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable Change Requests
Batch Records and associated documentation
Product and Component Release transactions in SAP
Quality Investigations (Deviations, Product Complaints)
Validation Plans, Protocols and Reports
Standard Operating Procedures

Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems
Executes QA processes including batch record review, product disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives
Interfaces with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensures GMP compliance during the planning, execution and closeout phases of these projects
Collaborates with, and influences, other PET/assigned area members to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices
Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to site leaders
Collaborates in data analysis and report creation on quality metrics and key performance indicators

Minimum Requirements

Bachelors degree required Preferred in Engineering / Technical or Healthcare related field
Excellent oral and written communication skills
Strong ability and motivation to learn

Preferred Background

Previous experience in a Lean, process-centric organization with emphasis on continuous improvement
Multi-site / multi-functional experience
5 years experience in Quality Assurance

Internal/External Contacts & Customers

PET members
QA and other support groups within or across sites
Supply Chain
Regulatory Affairs

Reporting Relationship

Direct Reports 0

Next Steps Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity If you know someone who would be a great fit, please share this posting with them

AstraZeneca embraces diversity and equality of opportunity We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills We believe that the more inclusive we are, the better our work will be We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements

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Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 18th Mar 2020

Key Skills:

Company Profile:


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